Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA

Stroke, Acute Clinical Trial

— OPHELIE  

Official title:

Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA in the Administered Rt-PA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614080
• Other study ID #: 10.677
• Secondary ID: 2010_04
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: December 18, 2014
• Start date: November 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).

Description:

OPHELIE is a multicenter study conducted in France in 25 centers where patients treated by iv rt-PA will be included. Patients are treated according to the local protocol, without any modification specifically for this study. A sample of 2 drops of the rt-PA used for the treatment is stored for analysis, to determine the sc-tPA/tc-tPA ration (immunostaining).

700 patients are needed for the study assuming that a difference of 5% will be found in the primary outcome measure (modified Rankin scale 0-1 at 3 months) with alpha and beta risks respectively of 5% and 20%.

The participating clinical centres recruit altogether more than 500 patients per year for thrombolysis. Assuming that 70% will be eligible, the recruitment should take less than 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being treated by iv tPA for acute cerebral ischaemia

Exclusion Criteria:

• absence of reliable informant

• no rtPA left in the syringe after treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Infarction
• Drug Toxicity
• Stroke, Acute

Locations

Country	Name	City	State
France	Lille University Hospital	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OPHELIE	The proportion of the patients with modified Rankin Scale 0-1	Month 3	No
Secondary	OPHELIE	The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition	7 days	No